Qualitech Validation & Compliance Solutions

cGMP, A COMPREHENSIVE MENU OF Validation & Compliance SERVICES

Call Center Review

We evaluate your call center on 98 best practices and recommend improvements.

Startup & commissioning

Qualitech Validation & Compliance engineers specializes in Start Up and Commissioning of small and large scale Biopharmaceutical Manufacturing and Medical Device production facilities. Unlike most commissioning agents out there today, we proactively commission and troubleshoot hardware and software issues in the field. We don’t just pencil whip documents or wait on the sidelines when a discrepancy or test fault is observed. We work with the owner and engineer to investigate the problem, suggest a solution and initiate a corrective action or change control immediately. Our past experience in design and operations of sanitary process equipment allows us to quickly move past issues that will delay construction, commissioning or qualification activities.
Our goal is to start up your facility to operate as intended by design and to meet the final user’s requirements. We will work with you to develop a commissioning plan that outlines the responsibilities of the design teams, construction contractors, commissioning agents and owner during the startup & commissioning phase. We have an extensive library of startup and commissioning templates and checklists that allow us to quickly apply our procedures and test plans to your specific project. We also identify the inspections and tests that can be leveraged into validation or qualification documents. This greatly minimizes document development time and allows for quicker document review, approval and field execution.
Poorly executed Commissioning efforts will result in delayed and costly validation and qualification activities.

PROJECTS

construction & project management

Qualitech Validation & Compliance Solutions range of construction and capital project services to the medical device, biotechnology and pharmaceutical industries. We understand the construction issues and pressures that arise when dealing with aggressive, fast paced, high tech, construction projects with tight budgets and tighter schedules. We facilitate cross-functional communication and coordination with the client and subcontracted trade services to ensure project requirements and timelines are met with a commitment to safety and quality. We assist our clients in establishing a transparent approach to project execution by documenting a clear definition of project objectives with roles and responsibilities that emphasize accountability with objective and measurable success criteria. .

Analysis & Strategy

Our experts are skilled with a variety of types of statistical analyses.

Cleanroom /Classified rooms qualification

Qualitech Validation & Compliance offers social media benchmarking and shopper experience assessment.

Free Support

+1.2818275401

validation & Qualification

Qualitech Validation & Compliance Solutions, LLC specializes in providing a broad range of, validation/qualification, commissioning, compliance and documentation services to the FDA

regulated pharmaceutical, biotechnology and medical device industries. Our regulatory and biopharmaceutical best practice know-how, combined with our risk management experience, helps clients achieve the most cost-effective compliance. We excel in project execution and serve as a strategic partner in GMP manufacturing facility qualification. We assist our clients to develop validation master and project plans that best utilize and leverage successful commissioning and verification activities. We work closely with each client to provide the desired level of detail and content to be written within their validation documents. We have an extensive library of engineering, qualification and validation templates, procedures and protocols that allow us to quickly apply our verification test procedures to validation and compliance projects to greatly minimize document development, review and approval time.

Our success stems from our ability to help our clients define appropriates systems boundaries with functional and performance specifications for which the systems and equipment is to be tested and verified. Errors during the functional specification review phase will have a tremendous impact on the efficiency of your validation project execution. It is imperative to catch errors on paper early during the design phase rather than construction or qualification phases.

CGmP Compliance (21 CFR Parts 11, 210, 211 & 600, 820)

We base our Validation & Compliance standards to the cGMP guidelines. Our consultants/Engineers are proficient in providing services in IQ/OQ & PQ protocol generation and execution, Commissioning and qualification, Validation of computerized systems, engineering studies, process Validation, Cleaning Validation, technology transfer and final reporting.

Periodic Validation Review Specialist

Perform periodic validation review of equipment qualification, computerized system validation, process validation, and cleaning validation, verifying maintenance of the validated state following initial implementation or prior periodic review.